Off-label marketing costs Pfizer

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Kai Ryssdal: So you go to your doctor, she gives you medicine. So far so good. Within the limits of ethics and good medical practice, she can prescribe almost anything she wants to treat whatever ailment you have. Where it gets tricky is when you bring pharmaceutical manufacturers into the equation.

They can only market the drugs they make to treat the specific illnesses the FDA has approved it to treat. To do otherwise is what you call off-label marketing. And that is why Pfizer's going have to come up with $2.3 billion in civil and criminal fines. From Washington, Marketplace's Tamara Keith reports.

TAMARA KEITH: Doctors prescribe drugs off-label all the time, often with good results. But there are down sides too.

Dr. Caleb Alexander at the University of Chicago cites a study that found nearly 75-percent of off-label drug uses lack scientific support.

CALEB ALEXANDER: We're talking about tens of millions of prescriptions a year. This is not a small volume of therapies.

There's big money in selling a drug for more than one use. And in this case Pfizer marketed uses that weren't approved, says Tony West, an assistant attorney general at the Justice Department.

TONY WEST: Pfizer asked the FDA if it could promote the sale of Bextra, which is an anti-inflammatory drug, for certain other uses and in doses which were higher than the approved maximum. The FDA, citing safety concerns, said no. But Pfizer marketed Bextra for those unapproved uses anyway.

Pfizer says it regrets actions taken in the past. Doctors learn about off-label uses from colleagues, journal articles, and continuing education courses often sponsored by drug companies.

Pfizer also supplied a curriculum that illegally pushed off-label uses of its drugs.

Dr. Alexander recently conducted a survey of physicians about several common drugs.

DR. ALEXANDER: We examined physicians use of Quetiapine to treat dementia with agitation.

That's an off-label use of the anti-psychotic drug. At the time of the survey, the FDA was advising doctors to be careful about using it in dementia patients.

DR. ALEXANDER: And yet, nearly one in five of the physicians we surveyed erroneously thought that it was FDA approved.